Hi-Tech Pharmacal granted final approval for generic Zantac syrup
AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.
The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.
Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.
Cephalon’s oncology portfolio to get boost with Gemin X acquisition
FRAZER, Pa. — Cephalon plans to acquire a privately owned company developing treatments for cancer, Cephalon said Monday.
The Frazer, Pa.-based drug maker said it would pay $225 million upfront for Malvern, Pa.-based Gemin X, and Gemin X stockholders would be eligible to receive up to $300 million in milestone payments related to products under development.
Gemin X specializes in cancer treatments that target and kill cancer cells. Its lead product is GX15-070 (obatoclax), currently in phase-2b clinical development as a treatment for small cell lung cancer.
“I am pleased to have entered into a merger agreement with Gemin X,” Cephalon CEO Kevin Buchi said. “Its array of novel, targeted cancer therapeutics is a welcome addition to our current oncology portfolio.”
Annual Diabetes Alert Day encourages public to know risk
ALEXANDRIA, Va. — The annual "wake-up call" that asks the American public to find out if they are at risk for developing Type 2 diabetes was held Tuesday.
The American Diabetes Association’s Diabetes Alert Day, which was held Tuesday, also marks the association’s Join the Million Challenge, which runs through April 22. The ADA encourages the public to take the diabetes risk test, which is available year-round and shows users whether they are at low, moderate or high risk for Type 2 diabetes.
Diabetes strikes nearly 26 million children and adults in the United States, according to the ADA. What’s more, an additional 79 million, or 1-in-3 American adults, have prediabetes, which puts them at high risk for developing Type 2 diabetes.
Click here to take the risk assessment.